BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3004123209-2015-00436

    MDR report key: 4782145 · Received April 24, 2015

    Report

    Report Number
    3004123209-2015-00436
    Event Type
    Malfunction
    Date Received
    April 24, 2015
    Date of Event
    April 20, 2015
    Report Date
    July 29, 2015
    Product Code
    MKJ
    PMA / PMN Number
    K123881
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    ROUTINE TESTING CONFIRMED THAT THIS DEVICE WAS INSTALLED BY THE CUSTOMER ON THE (B)(6) 2014 AND PERFORMED TO SPECIFICATION UP TO THE (B)(6) 2014. BETWEEN THE (B)(6) 2015 AND THE FINAL HISTORY LOG ENTRY ON THE (B)(6) 2015 THE DEVICE RECORDS MULTIPLE MANUAL POWER UPS OF LESS THAN ONE MINUTE DURATION. THE USER ACCESSIBLE MEMORY HAD BEEN ERASED PRIOR TO THE (B)(6) 2015 HOWEVER THE MEMORY LOG FOR THIS DATE INDICATES A FAULT WAS DETECTED ON THE MEMBRANE TRACK. A TEST PAD-PAK WAS INSERTED AND PASSED A SELF-TEST. THE INSTRUCTIONAL LEDS REMAINED ILLUMINATED DURING THE POWER CYCLE, INDICATING A FAULT. THE DEVICE MEMORY LOG WAS AGAIN DOWNLOADED AND CONFIRMED A FAULT ON THE MEMBRANE. DURING TESTING THE DEVICE WAS TESTED ON THE CALIBRATED EQUIPMENT USING A TEST POWER SUPPLY, THE DEVICE DELIVERED THE TEST THERAPY SEQUENCE WITHOUT FAULT AND AN ACCEPTABLE MEASUREMENT WAS RECORDED FOR THE TEST SHOCK. SEVERAL INSTRUCTIONAL LEDS REMAINED CONSTANTLY LIT. UPON VISUAL INSPECTION OF THE MEMBRANE CORROSION WAS FOUND. INVESTIGATION FOUND THE REPORTED FAULT CAN BE ATTRIBUTED TO MEMBRANE FAILURE DUE TO CORROSION ON THE MEMBRANE TAIL. THIS CAUSED A SHORT CIRCUIT AND RESULTED IN THE DEVICE SWITCHING AUTOMATICALLY UPON INSTALLATION OF THE PAD-PAK AND DAMAGE TO THE MICROPROCESSOR. CORROSION ON THE MEMBRANE TAIL SUGGESTS THE DEVICE HAD BEEN STORED IN ADVERSE ENVIRONMENTAL CONDITIONS.

    Description of Event or Problem · 1

    THERE WAS NO PT INVOLVED IN THIS EVENT. THE DEVICE MALFUNCTIONED, AS THE DEVICE IS SWITCHING ON AUTOMATICALLY WHEN PAD-PAK IS INSERTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    274680 MKJ
    274681 MKJ
    274787 HEARTSINE SAMARITAN 350P AND PAD PAK AUTOMATED EXTERNAL DEFIBRILLATOR MKJ PAD

    Patients

    Seq Age Sex Outcome Treatment
    1